A Study of TAK-861 in People With Narcolepsy Type 1

NCT06505031 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: TAK-861-30022024-511998-30-00
• Study Type: interventional
• Target: 105
• Locations: 10 countries
• Sites: 27

Brief Summary

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms and daily life functions; and to learn about the safety of TAK-861.

Conditions

Narcolepsy Type 1

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in Mean Sleep Latency From the 4 Maintenance of Wakefulness Test (MWT) Wake Trials

  The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.

  Baseline, Week 12

Secondary Outcomes (8)

• Change From Baseline to Week 12 in ESS Total Score

  Baseline, Week 12

• Weekly Cataplexy Rate (WCR) at Week 12

  Week 12

• Change From Baseline to Week 12 in Mean Number of Lapses on the 3 Psychomotor Vigilance Test (PVT)

  Baseline, Week 12

• Patient Global Impression of Change (PGI-C) Score at Week 12

  Week 12

• Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score

  Baseline, Week 12

Study Arms (2)

TAK-861

EXPERIMENTAL

Participants will receive TAK-861 tablets, orally, for 12 weeks.

Drug: TAK-861

Placebo

PLACEBO COMPARATOR

Participants will receive TAK-861-matching placebo tablets, orally, for 12 weeks.

Drug: Placebo

Interventions

TAK-861 DRUG

Oral tablet.

TAK-861

Placebo DRUG

TAK-861-matching placebo tablet.

Placebo

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m\^2).
• The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.
• The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
• The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) \[or less than one-third of the mean values obtained in normal participants within the same standardized assay\].

You may not qualify if:

• The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
• The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease).
• The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
• The participant has a history of cancer in the past 5 years.
• The participant has a clinically significant history of head injury or head trauma.
• The participant has a history of epilepsy, seizure, or convulsion.
• The participant has any current unstable psychiatric disorder or current active major depressive episode (MDE) or an active MDE in the past 6 months.

Sponsors & Collaborators

• Takeda: lead

Study Sites (28)

Takeda Site 1

Glebe, New South Wales, Australia

Location

Takeda Site 22

Linz, 4020, Austria

Location

Takeda Site 2

Alken, Belgium

Location

Takeda Site 3

Erpent, 5101, Belgium

Location

Takeda Site 25

Ghent, 9000, Belgium

Location

Takeda Site 24

Leuven, 3000, Belgium

Location

Takeda Site 23

Liège, 4000, Belgium

Location

Takeda Site 4

Beijing, Beijing Municipality, China

Location

Takeda Site 27

Zhengzhou, Henan, China

Location

Takeda Site 28

Shanghai, Shanghai Municipality, China

Location

Takeda Site 26

Guangdong, China

Location

Takeda Site 20

Helsinki, 380, Finland

Location

Takeda Site 21

Tampere, 33520, Finland

Location

Takeda Site 16

Léon, Bordeaux, 33076, France

Location

Takeda Site 6

Bron, France

Location

Takeda Site 14

Marseille, 13385, France

Location

Takeda Site 5

Montpellier, France

Location

Takeda Site 15

Nantes, 44093, France

Location

Takeda Site 7

Bologna, 40139, Italy

Location

Takeda Site 17

Pozzilli, 86077, Italy

Location

Takeda Site 8

Roma, Italy

Location

Takeda Site 9

Krakow, Poland

Location

Takeda Site 11

Seoul, Daegu, 41931, South Korea

Location

Takeda Site 10

Suwon, Gyeonggi-do, 16247, South Korea

Location

Takeda Site 12

Seoul, 3080, South Korea

Location

28003

Barcelona, 08035, Spain

Location

Takeda Site 13

Madrid, Spain

Location

Takeda Site 19

Uppsala, Sweden

Location

Related Links

• To obtain more information on the study, click here/on this link.

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: October 8, 2024
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

ES (2); FR (5); SE (1); PL (1); BE (5); AU (1); CN (4); FI (2); IT (3); KR (3)